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Posted: January 30, 2008

New Patent Awarded for Antigen-Sparing Vaccines that Elicit Robust Immunity

(Nanowerk News) A needle-free vaccine
platform that elicits a robust immune response against a wide array of
viruses and bacteria has been awarded a U.S. patent. The University of
Michigan holds the patent and NanoBio Corporation, a spin-off from the
university, licenses the patent and its associated technology.

The intranasal vaccines, produced using NanoBio's nanoemulsion
technology, have elicited a dramatic immune response in animals vaccinated
against influenza, anthrax, hepatitis B and other diseases. In some cases,
the immune response is exponentially higher than what is required to
provide adequate protection against infection. Such dramatic levels of
immunity would confer significantly higher levels of protection to the
vaccinated population at large compared with current injectable vaccines.

Because the vaccines trigger such robust immunity, scientists
anticipate they will be able to reduce vaccine antigen quantities to a
fraction of what current vaccines require, while still mounting an
overwhelming immune response.

This "antigen-sparing" capability would enable scientists to rapidly
produce large quantities of vaccines using miniscule amounts of antigen, a
critical factor when faced with a disease pandemic or biological warfare.

"We've shown that when we mix our nanoemulsion with whole virus or a
recombinant protein antigen and apply it to the naso-pharynx, the resulting
vaccine elicits strong mucosal and systemic immunity," said James R. Baker
Jr., M.D., founder and Chairman of NanoBio Corporation. "The nanoemulsion
serves as an adjuvant to boost immune response against a specific antigen."

NanoBio is in various stages of testing its extensive pipeline of
mucosal vaccines for influenza, bird flu, hepatitis B, HIV, RSV, small pox,
anthrax and other viral and bacterial infections. Final results from the
influenza vaccine study in ferrets are expected this quarter, and human
tests with the influenza and hepatitis B vaccines are being planned.

The newly awarded patent covers the methods and compositions of
formulating nanoemulsion vaccines, a unique coupling of oil, water, and
antimicrobial surfactant together with antigens from specific pathogens.

Studies in animals demonstrate these vaccines easily penetrate the
mucous membrane, where dendritic cells rapidly engulf the antigen and
present it to the immune system. This rapid awakening of the immune system
via the intranasal route negates the need for inflammatory stimulants used
in traditional vaccines, which can cause pain and swelling at the site of
vaccination, said Dr. Baker.

"We present antigen in an optimal location where it can most directly
access the immune system," added Baker. "As a result, there is no need to
prime the immune system with immunostimulants in order to provoke its
recognition of the antigens."

Moreover, the vaccine requires no harsh chemicals to attenuate the
whole virus and render it harmless, because the nanoemulsion itself kills
the antigen. Advantages of the nanoemulsion vaccines include:

nasal delivery, the entry point of most respiratory infections

development of rapid mucosal immunity followed by systemic immunity

antigen-sparing capability

thermally stable, requires no refrigeration

needle-free, easy to administer

The development of the nanoemulsion platform began in 1998 and is
supported, in part, by a $6.3 million grant from the Bill and Melinda Gates
Foundation to the Michigan Nanotechnology Institute for Medicine and
Biological Sciences, which is led by Dr. Baker. The new patent for
nanoemulsion vaccines (#7,314,624 B2) is licensed to NanoBio Corporation on
an exclusive, worldwide basis. With this new patent, NanoBio now holds five
U.S. patents and has filed numerous additional applications in various
jurisdictions.

About NanoBio

NanoBio® Corporation is a privately held biopharmaceutical company
focused on developing and commercializing anti-infective products and
mucosal vaccines derived from its patented NanoStat™ technology
platform. The company's lead product candidates are treatments for herpes
labialis (cold sores), onychomycosis (nail fungus), MRSA and mucosal
vaccines for influenza and hepatitis B. The company's headquarters and
laboratory facilities are located in Ann Arbor, Mich.